Study to Explore Drug-drug Interactions Between DWC20155 and DWC20156 in Healthy Subjects

• Sponsor: Daewoong Pharmaceutical Co. LTD. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02704559
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 2
• Duration (Months): 2
• Patients Per Site Per Month: 19.6

Study Details

Study Description

Brief Summary

A randomized, open-label, oral dose, crossover study to explore drug-drug interactions between DWC20155 and DWC20156 in healthy subjects.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: DWC20155; Drug: DWC20156	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Study Start Date: Dec 1, 2015
• Actual Primary Completion Date: Feb 1, 2016
• Actual Study Completion Date: Feb 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Study effect of DWC20156 on DWC20155 PK To study effect of DWC20156 on DWC20155 PK	Drug: DWC20156
Experimental: Study effect of DWC20155 on DWC20156 PK To study effect of DWC20155 on DWC20156 PK	Drug: DWC20155

Outcome Measures

Primary Outcome Measures

1. Peak Plasma Concentration (Cmax) [0~24hr]

2. Area under the plasma concentration versus time curve (AUC) [0~24h]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Accepts healthy volunteers.

Exclusion Criteria:

• Who has allergy to investigational product

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Busan Paik Hospital	Busan		Korea, Republic of

Sponsors and Collaborators

• Daewoong Pharmaceutical Co. LTD.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Daewoong Pharmaceutical Co. LTD.
• ClinicalTrials.gov Identifier: NCT02704559
• Other Study ID Numbers: DW_DWJ1366001
• First Posted: Mar 10, 2016
• Last Update Posted: Feb 16, 2017
• Last Verified: Feb 1, 2017

Study Results

No Results Posted as of Feb 16, 2017